What are the responsibilities and job description for the CFR 820 Equipment/Calibration Engineer (ONSITE) position at NetSource, Inc.?
Job Details
Please note that this is a 6-month contract position.
- Experience working in the Medical Device/Pharma/Biotech field
- Experience with computerized management systems, such as SAP, Maximo, BMRAM or CERDAAC or equivalent
- Solid understanding of ISO 9001/13485, 21 CFR 820, cGMP, GXP and good documentation practices
- Efficiency with Microsoft Office Products such as Word and Excel or equivalent software application
Qualifications
Bachelor's Degree in Engineering or technical certifications in a related field is required.
Required Skills and Experience:
- Minimum 2 years of proven performance ability working as an Equipment Calibration Engineer or Sr. Equipment calibration Technician in a high-volume manufacturing environment
- Experience in review & approval of specification of Calibration, Maintenance, and qualification documentation
- Able to analyze data, compile reports, and recommend corrective action
- Basic knowledge in the areas of Design Controls Processes, Equipment Validation, Manufacturing practices/principles, and statistical techniques
- Outstanding organization, communication, presentation, and interpersonal skills working within the organization
- Able to work independently, efficiently, and collaboratively with all levels of employees and management
- Flexibility to support changing assignments and priorities in an independent and reliable manner while maintaining a positive and collaborative demeanor
Duties and Responsibilities
- Works directly with customers, engineering, manufacturing and other groups to develop appropriate equipment specifications for calibration and preventative maintenance (PM), such as parameters, intervals, tolerances, acceptance criteria, and operating limits for new and existing equipment and systems.
- Review all equipment specifications and records information for completeness and appropriateness.
- Provides communication, direction, mentoring, training, and guidance for employees.
- Review and approval of Calibration, PM, documents and reports.
- Manages service providers to ensure scheduling in accordance with Cal and PM due dates; coordinates the testing, monitoring, and inspecting processes of equipment calibration and PM
- Collect, report, and maintain calibration and preventive maintenance performance data into Computerized Maintenance Management System (CMMS).
- Collaborates with multi-functional groups to resolve calibration/maintenance issues, support non-conformance investigations, improve equipment reliability, review procedures, and minimize equipment downtime.
- Participates in product, project, and process development teams to provide quality support and mentorship.
- Supports all audits.
- Other related duties may be assigned
Applicants must provide their phone number. Reference job number A4584.
